Study Of Oral Ozanimod As Induction Therapy For Moderately To Severely Active Crohn’s Disease

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Study Overview

Have you been diagnosed with or have signs and symptoms of moderately to severely active Crohn’s disease (CD)? Have you not improved on or have not been able to tolerate at least one prior CD medication? If so, you may be eligible for a paid clinical trial using an oral medication (Ozanimod) to treat CD! 

Study Description

The purpose of this phase III study is to confirm preliminary results from a phase II study that suggest that ozanimod may be safe and effective for people with CD.  To do this, a comparison will be made between study participants who receive ozanimod and study participants who receive placebo (a capsule that looks like ozanimod but contains no drug in it).

Ozanimod is a chemical compound that is thought to act on the immune system by making certain types of white blood cells (lymphocytes including T cells) stay in the lymph nodes and other places in the body, keeping them away from sites of inflammation.  
Ozanimod has not been approved in the United States by the U.S. Food and Drug Administration (FDA) for sale for the treatment of CD and its use in this study is investigational which means that it is being tested because not all information is available on how the drug works in the body. 

This study includes the testing of blood, tissue, and stool samples. If screening tests show that you are eligible to participate you will be asked to complete another 4 study visits over the following 12 weeks at which point you will be given the option to continue to either the Maintenance Period or Open-Label Extension.

Additional Information:

Please contact the study coordinator Rupa Chowdary via email rupa.chowdary@pennmedicine.upenn.edu or by phone at 215-573-5073 for more information.

  • Study Identifier: 831740

Recruitment Status

Open

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